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ViiV HEALTHCARE'S CABOTEGRAVIR FOR HIV PREVENTION RECEIVES POSITIVE CHMP OPINION FROM EUROPEAN MEDICINES AGENCY
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• Cabotegravir is the first and only long-acting injectable option for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1
• Positive opinion is based on results from the HPTN 083 and 084 phase IIb/III studies in which the medicine, given as few as six times per year, demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition1,2,3,4
• With approximately 100,000 people in Europe newly diagnosed with HIV each year,5 this is an important step towards expanding HIV prevention options in the region
London, 24 July 2023 - ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, welcomed a positive opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for cabotegravir long-acting (LA) injectable and tablets for HIV prevention. Cabotegravir is recommended in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents weighing at least 35 kg.
In Europe, strong progress has been made in the delivery of HIV treatment and prevention services, seeing a continuous decline in the incidence of new HIV cases. However, with approximately 100,000 new diagnoses each year, if approved, cabotegravir LA will be the only prevention option for people at risk of HIV acquisition that is administered as few as six times per year.5
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: "The expansion of prevention options is critical if we are to end the HIV epidemic. Long-acting options have the potential to play an important role in reducing challenges such as inconsistent adherence to taking daily pills, and stigma associated with oral PrEP use that can be faced by people who could benefit from PrEP. At ViiV Healthcare we are at the forefront of cutting-edge science, developing innovative solutions to address the biggest unmet needs in HIV prevention. With the CHMP positive opinion, we are hopeful that people in Europe will soon be able to benefit from greater choice".
The positive opinion is supported by data from two international phase IIb/III multicentre, randomised, double-blind, active controlled studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir LA for PrEP in HIV-negative men who have sex with men, transgender women, and cisgender women who were at increased risk of acquiring HIV. The studies demonstrated that cabotegravir LA for PrEP was superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), with clinical trial participants given cabotegravir LA experiencing a 69% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 083 (12 vs 39; annual incidence: 0.37% vs 1.22%; HR 0.31 [CI: 0.16, 0.58]) , and a 90% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 084 (3 vs 36; annual incidence: 0.15% vs 1.85%; HR 0.10 [CI: 0.04, 0.27]).1,2,3,4
Cabotegravir LA for PrEP is currently approved for use in the US, Australia, Zimbabwe, South Africa, Malawi, Botswana, and Brazil as Apretude. Submission to other regulatory agencies is on-going.
About cabotegravir extended-release injectable suspension
Cabotegravir long-acting for HIV prevention is the first and only long-acting injectable PrEP option proven superior to daily oral FTC/TDF in reducing HIV acquisition.
Cabotegravir long-acting for PrEP is an integrase strand transfer inhibitor (INSTI).
INSTIs, like cabotegravir extended-release injectable suspension, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease.
Cabotegravir long-acting for PrEP is provided as an injection administered six times per year by a healthcare professional and is initiated with a single 600 mg (3-ml) injection given one month apart for two consecutive months. After the second initiation injection, the recommended continuation injection dose is a single 600 mg (3-ml) injection given every two months. Cabotegravir oral tablets may be administered for approximately one month before initiating the first injection to assess the tolerability of the medicine.
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